Category: Press Releases

NeurOp, Inc., a clinical-stage biotechnology company, today announced the initiation of a Phase 1 clinical trial of NP10679, a highly potent and selective GluN2B subunit-specific NMDA (N-methyl-D-aspartate) receptor inhibitor. NeurOp is investigating NP10679 for several neurological disorders that are associated with over-activity of these receptors.

The randomized, placebo-controlled, single ascending dose study will assess the safety, pharmacokinetics and pharmacodynamics of NP10679 in healthy volunteers. The study is being conducted in collaboration with Pharmaron (Baltimore) and is currently enrolling subjects in the United States. Data collected from the study will inform dose and schedule for further development of NP10679 for potential use in severe pain and the prevention of ischemic damage following subarachnoid hemorrhage (SAH).

Certain areas of the brain become acidified by metabolic insufficiency or increased neuronal activity. This condition or “context” exists in severe pain and SAH and may also exist in brain areas that are undergoing seizures or involved in nicotine or opioid addiction.

“NP10679 is a first-in-class therapy as a context-dependent NMDA receptor inhibitor,” said NeurOp’s Chief Scientific Officer, Robert Zaczek, PhD. “Preclinical data demonstrate that NP10679 is different from other NMDA therapies, because of its selectivity, safety profile and potency at low pH, a condition found in a number of central nervous system disorders.”

“We have achieved a significant milestone for NeurOp now that NP10679 has advanced to the clinic,” said James McNamara, MD, Executive Chairman at NeurOp. “We look forward to moving this compound through clinical development and are particularly encouraged by its potential as a treatment for severe pain. With the opioid epidemic facing the nation, the need for effective and safe medications for severe pain is greater than ever.”

NP10679 is bioavailable either orally or by IV, and it is currently being evaluated in this study by the IV route. An IND for NP10679 was opened in 2016.

About NeurOp
NeurOp, Inc. is a clinical-stage biopharmaceutical company based in Atlanta that is developing small-molecule therapies for central nervous system disorders, including severe pain, subarachnoid hemorrhage (SAH) and catastrophic juvenile epilepsies. Its proprietary compounds selectively inhibit the GluN2B subunit of neuronal NMDA receptors for potential therapeutic benefit with fewer side effects than currently available NMDA receptor antagonists. For more information, please visit www.neuropinc.com.

NP10679 is in development to prevent brain ischemia during stroke or subarachnoid hemorrhage

NeurOp, Inc. today announced that it has received a $3.5 million award from the National Institute of Neurological Disorders and Stroke (NINDS), a division of the NIH, to begin clinical testing of the Company’s drug candidate NP10679, a GluN2B subunit-specific NMDA (N-methyl-D-aspartate) inhibitor. NeurOp is investigating NP10679 for the prevention of ischemic damage during a stroke or subarachnoid hemorrhage (SAH).

“We designed NP10679 with great care to incorporate the attributes we believe differentiate this molecule from other NMDA inhibitors in development,” said Barney Koszalka, PhD, NeurOp CEO. “For example, the binding of the molecule is enhanced in an acidic environment, a property other NMDA inhibitors lack. This property of pH dependence improves the chance of achieving efficacy at dose levels devoid of side effects. We would like to partner with a pharmaceutical company in future trials to fully explore this advantage in an array of disorders such as stroke, treatment-resistant depression and neuropathic pain.”

NP10679 is bioavailable by either the oral or IV route, and it will initially be evaluated in a Phase 1 study in healthy human volunteers by the IV route. The study is expected to start in early 2018. Pre-clinical studies have shown efficacy in treating complications associated with SAH. An IND for NP10679 was opened in 2016.

NeurOp’s Chief Scientific Officer, Robert Zaczek, PhD, added, “The safety profile of NP10679 allows for prophylactic use in patients at risk for an ischemic event, such as those suffering an SAH. This is important because extensive data has shown that early intervention is key for robust efficacy of neuroprotective therapy. Our prophylactic intervention strategy will place NP10679 at its site of action before an SAH-driven delayed cerebral ischemia event takes place. This eliminates the time-of-dosing caveat that might, in part, have led to previous failures of clinical tests involving glutamatergic agents in stroke and head trauma.”

Note: Research reported in this news release is supported by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health (NIH) under Award Number R44NS071657. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

About NeurOp
NeurOp, Inc. is an Atlanta-based biopharmaceutical company developing new medicines for central nervous system disorders, including depression, neuropathic pain, ischemia (stroke), schizophrenia and Parkinson’s disease. Its research targets specific subunits of neuronal NMDA receptors to identify and evaluate small molecule modulators for potential therapeutic benefit. Multi-year funding from the NIH supports the Company’s research and development programs for NP10679 for the prevention of ischemic damage during a stroke or subarachnoid hemorrhage. For more information, please visit www.neuropinc.com.

NeurOp, Inc. today announced that Lee H. Latimer, Ph.D., head of chemistry, has been elected as Director-at-Large for the American Chemical Society’s (ACS) 2016 Board of Directors. The Society announced election results on November 5.

Dr. Latimer has been a member of ACS since 1972 and became an ACS Fellow in 2012. He has held leadership positions at the local and national level of the organization and been recognized with a number of awards for his contributions.

“ACS is about opportunity for its members in so many ways. It has certainly been so for me. I enjoy meeting new challenges and colleagues in teams and applying my experience to make a difference,” said Latimer.

Dr. Latimer earned his Ph.D. in organic chemistry from the University of Wisconsin under the mentorship of B.M. Trost and held an NIH Fellowship with W.G. Dauben at the University of California at Berkeley and C.J. Sih at the University of Wisconsin at Madison. To learn more about Dr. Latimer’s extensive professional experience, click here.

About NeurOp
NeurOp, Inc. is an Atlanta-based biopharmaceutical company developing new medicines for central nervous system disorders, including depression, neuropathic pain, ischemia (stroke), schizophrenia, and Alzheimer’s and Parkinson’s diseases. Its research targets various subunits of neuronal NMDA receptors and their potential therapeutic benefit. The company has licensed its technology to Bristol-Myers Squibb for the development of a compound for treatment-resistant depression. Multi-year funding from the NIH supports the company’s research and development programs for schizophrenia, Alzheimer’s disease and NP10679, its drug candidate for the prevention of ischemic damage during a stroke or subarachnoid hemorrhage. For more information, please visit www.neuropinc.com.

NeurOp, Inc. today announced that it has entered into a research collaboration with Janssen Pharmaceuticals, Inc. to better understand how modulating the NMDA (N-methyl-D-aspartate) receptor impacts pathways related to different central nervous system disorders.

Under the agreement, which was facilitated by the Johnson & Johnson Innovation Center in Boston, NeurOp and Janssen will focus specifically on the modulation of the 2C and 2D subunits of the NMDA receptor and their potential to impact central nervous system disorders such as depression. Financial terms of the agreement were not disclosed.

“Glutamate signaling through NMDA receptors is one of the most important processes in normal brain function, particularly in emotional processing,” said Barney Koszalka, Ph.D., NeurOp CEO. “NeurOp and Janssen see this as a tremendous opportunity to investigate the use of NMDA modulators, which could lead to new treatments for patients afflicted with a number of central nervous system disorders.”

About NeurOp
NeurOp, Inc. is an Atlanta-based biopharmaceutical company developing new medicines for central nervous system disorders, including depression, neuropathic pain, ischemia (stroke), schizophrenia, and Alzheimer’s and Parkinson’s diseases. Its research targets various subunits of neuronal NMDA receptors and their potential therapeutic benefit. The company has licensed its technology to Bristol-Myers Squibb for the development of a compound for treatment-resistant depression. Multi-year funding from the NIH supports the company’s research and development programs for schizophrenia, Alzheimer’s disease and NP10679, its drug candidate for the prevention of ischemic damage during a stroke or subarachnoid hemorrhage. For more information, please visit www.neuropinc.com.

NeurOp, Inc. today announced that Bristol-Myers Squibb has selected an NR2B-specific N-methyl-D-aspartate (NMDA) receptor modulator as a drug development candidate for treatment-resistant depression. This decision triggers a milestone payment to NeurOp, which licensed its technology to Bristol-Myers Squibb in 2009. The compound can now advance into pre-IND studies.

“The team at Bristol-Myers Squibb has been a dedicated, insightful research partner as we have worked together for more than three years to identify and advance a new drug candidate,” commented Barney Koszalka, Ph.D., NeurOp president and CEO. “Reaching this clinical and financial milestone is important to NeurOp, because it will help support our R&D on additional subunits of the NMDA receptor as treatments for other central nervous system disorders.”

Under the terms of the agreement, Bristol-Myers Squibb agreed to pay NeurOp an upfront fee and fund a multi-year research collaboration. The direct research collaboration ended in December 2012, and the program was fully internalized at Bristol-Myers Squibb. NeurOp is eligible to receive additional milestone payments for the successful development of a compound and royalties on worldwide sales of commercialized compounds. Financial terms of the current milestone were not disclosed.

About Treatment-Resistant Depression
Unlike normal emotional experiences of sadness, loss or passing mood states, major depressive disorder (MDD) is persistent and can significantly interfere with thoughts, behavior, mood, activity and physical health. According to the National Institute of Mental Health, MDD is the leading cause of disability in the U.S. for people aged 15 to 44 and affects almost 15 million adults, or about 6.7 percent of the population in a given year. Up to 15 percent of people with MDD die by suicide. About one-third of people suffering from depression do not get relief from first-line antidepressant medications. Of significant concern is the fact that even when effective there is a delay in onset of action of two weeks or more, during which time patients are at increased risk of suicide.

About NeurOp
NeurOp, Inc. is an Atlanta-based biopharmaceutical company developing new medicines for central nervous system disorders, including depression, neuropathic pain, ischemia (stroke), schizophrenia, and Alzheimer’s and Parkinson’s diseases. Its research targets various subunits of neuronal NMDA receptors and their potential therapeutic benefit. The company has licensed its technology to Bristol-Myers Squibb for the development of a compound for treatment-resistant depression. Multi-year funding from the NIH supports the company’s research and development programs for schizophrenia, Alzheimer’s disease and NP10679, its drug candidate for the prevention of ischemic damage during a stroke or subarachnoid hemorrhage. For more information, please visit www.neuropinc.com.

NeurOp, Inc. announced today that the National Institutes of Health (NIH) has awarded it a grant to support research on new Alzheimer’s disease treatments. NeurOp is investigating subunit-selective N-methyl D-aspartate (NMDA) receptor compounds as potential therapeutics. The grant is a one-year award and will be conducted in collaboration with Dr. Jon Johnson at the University of Pittsburgh.

“Alzheimer’s disease has devastating effects on patients and their families,” said Barney Koszalka, Ph.D., NeurOp president and CEO. “Our research suggests that targeting specific subunits of NMDA receptors may lead to a new generation of drugs that may enhance cognitive performance, as well as impact the progression of other diseases of the central nervous system. This is the third grant we’ve received from the NIH to fund research based on our NMDA receptor modulation platform, and we look forward to further exploring the potential it has for patients.”

This project is supported by the National Institute on Aging of the National Institutes of Health under award number R41AG048723.

About NeurOp
NeurOp, Inc. is an Atlanta-based biopharmaceutical company developing new medicines for central nervous system disorders, including depression, neuropathic pain, ischemia (stroke), schizophrenia, and Alzheimer’s and Parkinson’s diseases. Its research targets various subunits of neuronal NMDA receptors and their potential therapeutic benefit. The company has licensed its technology to Bristol-Myers Squibb for the development of a compound for treatment-resistant depression. Funding from the NIH supports the company’s research and development programs for schizophrenia, Alzheimer’s disease and NP10679, its drug candidate for the prevention of ischemic damage during a stroke or subarachnoid hemorrhage. For more information, please visit www.neuropinc.com.

NeurOp, Inc. announces that Lee H. Latimer, Ph.D., has been appointed as its head of chemistry. He will oversee the company’s chemistry program to support its drug development initiatives for the treatment of depression, neuropathic pain, ischemia (stroke), schizophrenia and other central nervous system disorders.

Dr. Latimer was most recently a consultant to the pharmaceutical and biotechnology industries and provided expertise in process, analytical and medicinal chemistry. Prior to that, he was the senior director of process and analytical chemistry at Elan Pharmaceuticals. He successfully led in-house and outsourced oversight and development of GMP routes to five clinical candidates in its Alzheimer’s disease and multiple sclerosis programs. Dr. Latimer is also an inventor of semagacestat, which reached phase III clinical trials for Alzheimer’s disease in collaboration with Eli Lilly.

“Lee brings a wealth of development experience to NeurOp at a time when our internal programs are advancing into clinical development,” said Barney Koszalka, Ph.D., president and CEO at NeurOp. “His work in early-stage medical chemistry programs will also greatly contribute to our ongoing efforts to develop new modulators of the NMDA receptor through our collaboration with Emory University.”

Dr. Latimer earned his Ph.D. in organic chemistry from the University of Wisconsin under the mentorship of B.M. Trost and held an NIH Fellowship with W.G. Dauben at the University of California at Berkeley and C.J. Sih at the University of Wisconsin at Madison. He is an American Chemical Society Fellow.

About NeurOp

NeurOp, Inc. is an Atlanta-based biopharmaceutical company developing new medicines for central nervous system disorders, including depression, neuropathic pain, ischemia (stroke), schizophrenia, and Alzheimer’s and Parkinson’s diseases. Its research targets various subunits of neuronal NMDA receptors and their potential therapeutic benefit. The company has a research collaboration and licensing agreement with Bristol-Myers Squibb for the development of NeurOp’s compounds for the treatment of depression and neuropathic pain. Multi-year funding from the NIH supports the company’s research and development programs for schizophrenia and NP10679, its drug candidate for the prevention of ischemic damage. For more information, please visit www.neuropinc.com.

NeurOp, Inc. has selected NP10679 as a development candidate for the prevention of ischemic damage and its consequences in persons receiving surgical treatment for subarachnoid hemorrhage (SAH). NP10679 is a GluN2B subunit-specific modulator designed to work at the site of ischemic insult.

NeurOp has begun late-stage preclinical development studies with this candidate with the goal to file an IND in 2015.

The manuscript demonstrates that the use of a pH-dependent NMDA antagonist has the potential to work selectively in areas of ischemia known to undergo acidic pH shifts, which occur during SAH. Because of their regional selectivity, these NMDA antagonists may also be associated with fewer behavioral side effects than non-selective NMDA antagonists.

NeurOp, Inc. has received $700,000 in funding as part of a $3 million National Institutes of Health (NIH) award to support its cerebral ischemia development program. This third year of funding from the NIH will support pre-IND and additional efficacy studies for NeurOp’s proprietary development candidate. First announced in July 2011, the NIH grant is a four-year award that provides annual financial support to NeurOp upon successfully meeting its scientific and development milestones.

“We identified a development compound last year with unique characteristics that modulate over-active NMDA receptors through a specific subunit,” commented Barney Koszalka, Ph.D., CEO of NeurOp. “Our primary focus with this compound is to develop it for treating patients that have suffered a subarachnoid hemorrhage (SAH).”

NeurOp will initially study its candidate as a prophylactic treatment for SAH patients, which comprise up to seven percent of all stroke victims. Since about half of SAH patients suffer a stroke-like event within 14 days after surgery to repair the cerebral aneurysm, drug administration would begin immediately after surgery and be maintained through this critical period to improve survival and reduce neurological and cognitive insults should a stroke occur. If the compound proves safe and effective in SAH, NeurOp believes this approach can be expanded into other patients at risk of ischemic or traumatic brain injury, providing a much-needed new therapy to address these serious and costly areas of medical need.

This project is supported by Award Number U44NS071657 from the National Institute of Neurological Disorders and Stroke (NINDS).

NeurOp, Inc. has received $346,000 from the National Institutes of Health (NIH), the second half of a $700,000 grant made last year to support its schizophrenia treatment research. NeurOp is studying NR2C and NR2D subunit-selective NMDA receptor compounds as potential new antipsychotic medications.

“This grant required that we meet certain research objectives to qualify for the second year of funding, and I’m pleased to say that we accomplished those,” said Barney Koszalka, Ph.D., NeurOp president and chief executive officer. “In the next 12 months, our goal is to use these funds to advance the medicinal chemistry and pharmacology work that are needed to complete a proof of concept in animals.”

This project is supported by the National Institute of Mental Health of the National Institutes of Health under award number R43MH096363. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About Schizophrenia

Schizophrenia is a complex, disabling and chronic brain disorder that typically strikes in the early adult years and affects one percent of the world’s population. According to the National Institute of Mental Health, people with the disorder may hear voices that others do not. They may also believe other people are reading their minds, controlling their thoughts, or plotting to harm them. This can terrify people with the illness and make them withdrawn or extremely agitated. Symptoms such as hallucinations and delusions usually start between ages 16 and 30.

Because the causes of schizophrenia are unknown, treatments focus on eliminating the symptoms and include antipsychotic medications, designated as typical and atypical, and various psychosocial treatments.

About NeurOp

NeurOp, Inc. is an Atlanta-based biopharmaceutical company developing new medicines for central nervous system disorders, including depression, neuropathic pain, ischemia (stroke), schizophrenia, and Alzheimer’s and Parkinson’s diseases. Its research targets various subunits of neuronal NMDA receptors and their potential therapeutic benefit. A research collaboration and licensing agreement with Bristol-Myers Squibb currently funds and supports development of NeurOp’s compounds for the treatment of depression and neuropathic pain. Multi-year funding from the NIH supports its ischemia and schizophrenia research. For more information, please visit www.neuropinc.com.